Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, the House Energy & Commerce Committee help a markup of 44 pieces of legislation, including healthcare-related bills, and the Biden Administration announced actions to lower health care and prescription drug costs by promoting competition. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On December 4, 2023, the Centers for Disease Control (CDC) released a notice entitled, Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Request for Comment. The CDC opened the docket to obtain comment on and review of proposed modifications to data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and proposed modifications to data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).
• On December 4, 2023, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Application by the Utilization Review Accreditation Commission (URAC) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program. In Notice document, 2023-24850, appearing on pages 77321 through 77323, in the issue of Thursday, November 9, 2023, make the following correction: On page 77321, in the second column, in the DATES section, the date “December 11, 2023” should read “December 8, 2023.”
• On December 4, 2023, CMS issued an interim final rule entitled, Medicaid; CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act. This interim final rule with request for comments (IFC) implements reporting requirements and enforcement authorities in the Social Security Act (the Act) that were added by the Consolidated Appropriations Act, 2023 (CAA, 2023). CMS will use these new enforcement authorities as described in this rule if States fail to comply with the new reporting requirements added by the CAA, 2023 or with Federal Medicaid eligibility redetermination requirements during a timeframe that is generally aligned with the period when States are restoring eligibility and enrollment operations following the end of the Medicaid continuous enrollment condition under the Families First Coronavirus Response Act (FFCRA). The new enforcement authorities include requiring States to submit a corrective action plan, suspending disenrollments from Medicaid for procedural reasons, and imposing civil money penalties (CMPs). They also include applying a reduction to the State-specific Federal Medical Assistance Percentage (FMAP) for failure to meet reporting requirements.
• On December 4, 2023, the Food and Drug Administration (FDA) released a notice entitled, Issuance of Priority Review Voucher: Rare Pediatric Disease Product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of priority review voucher. FDA has determined that XENPOZYME (olipudase alfa-rpcp), manufactured by Genzyme Corporation, meets the criteria for a priority review voucher.
• On December 4, 2023, FDA released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) and the Office of Vaccines Research and Review (OVRR) have modified organizational structures.
• On December 5, 2023, FDA issued a final rule entitled, New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address. The FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
• On December 5, 2023, the National institutes of Health (NIH) issued a notice entitled, Government Owned Inventions. The invention listed below is directed to a device to measure placental oxygen saturation in pregnant women from 20 weeks of pregnancy to delivery. The device monitors maternal tissue oxygen saturation, blood oxygen saturation, breathing rate, heart rate, and heart rate variability from signal, fetal movement activity and potentially fetal heart rate and heart rate variability. This technology was discovered and is being developed by the National Institute on Child Health and Human Development (NICHD). The NICHD is currently seeking a licensee and/or collaborator to further develop this technology.
• On December 6, 2023, CMS issued a notice entitled, Medicare and Medicaid Programs; Application from the Joint Commission (TJC) for Initial Approval of its Rural Health Clinic (RHC) Accreditation Program. This proposed notice acknowledges the receipt of an application from the Joint Commission (TJC) for initial recognition as a national accrediting organization (AO) for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
• On December 6, 2023, FDA issued a notice entitled, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability. The guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, the guidance covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as “trading partners”) after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns. The guidance finalizes the revised draft guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, issued on March 10, 2022.
• On December 6, 2023, FDA issued a notice entitled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. The draft guidance describes FDA’s interim policy regarding the use of bulk drug substances in compounding by outsourcing facilities while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the FD&C Act. This draft guidance, when finalized, will replace the guidance for industry entitled, “Interim Policy on Compounding Using Bulk Drug Substances Under section 503B of the Federal Food, Drug, and Cosmetic Act.
• On December 6, 2023, FDA issued a notice entitled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. The draft guidance describes FDA’s interim policy regarding the use of bulk drug substances by human drug compounders that are not registered with FDA as outsourcing facilities while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the FD&C Act. This draft guidance, when finalized, will replace the guidance for industry entitled, Interim Policy on Compounding Using Bulk Drug Substances under section 503A of the Federal Food, Drug, and Cosmetic Act issued in January 2017.
• On December 7, 2023, FDA issued a notice entitled, Dr. Reddy’s Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction. This notice is correcting a notice that appeared in the Federal Register on October 4, 2023. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy’s Laboratories, Inc., withdrawn as of November 3, 2023. The document indicated that FDA was withdrawing approval of ANDA 203807, clozapine tablets, 25 milligrams (mg), 50 mg, 100 mg, and 200 mg, held by Dr. Reddy’s Laboratories, Inc., U.S. Agent for Dr. Reddy’s Laboratories SA, 107 College Rd. East, Princeton, NJ 08540. Before FDA withdrew the approval of this ANDA, Dr. Reddy’s Laboratories, Inc., informed FDA that it did not want the approval of the ANDA withdrawn. Because Dr. Reddy’s Laboratories, Inc., timely requested that approval of ANDA 203807 not be withdrawn, the approval is still in effect. This notice corrects that error.
• On December 7, 2023, FDA issued a notice entitled, Bayer HealthCare Pharmaceuticals Inc., et al.; Withdrawal of Approval of CIPRO (Ciprofloxacin Hydrochloride) Oral Tablet, Equivalent to 100 Milligrams Base, and Five Generic Ciprofloxacin Hydrochloride, Oral Tablet, Equivalent to 100 Milligrams Base Drug Products. The FDA is withdrawing the approval of CIPRO (ciprofloxacin hydrochloride (HCl)) oral tablet, equivalent to (EQ) 100 milligrams (mg) base under new drug application (NDA) 019537 and five generic ciprofloxacin HCl, oral tablet, EQ 100 mg base products which referenced it as their basis of submission. The holders of the applications requested withdrawal of the 100 mg strength products and waived their opportunity for a hearing.

Event Notices

• December 12 and 13, 2023: CDC announced the Advisory Council for the Elimination of Tuberculosis (ACET) will hold a meeting open to the public.
• December 13 and 14, 2023: The Department of Health and Human Services (HHS) announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
• December 14 and 15: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
• December 20: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
• January 24, 2024: NIH announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.
• February 2, 2023: FDA announced the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
• February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee hill hold a meeting that is open to the public.

II. Hearings & Markups

U.S. Senate

• On December 5, the Senate Finance Committee hosted a hearing entitled, Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective. Witnesses present included Inmaculada Hernandez, PharmD., Ph.D., Professor, Division Of Clinical Pharmacy, Skaggs School Of Pharmacy And Pharmaceutical Sciences, University of California, San Diego; Marta E. Wosińska, Ph.D., Senior Fellow, Schaeffer Initiative On Health Policy, The Brookings Institution; Allan Coukell, Senior Vice President Of Public Policy, Civica Rx; and Jason Westin, MD, MS, FACP Director, Lymphoma Clinical Research Program, Section Chief, Aggressive Lymphoma, Department Of Lymphoma & Myeloma, M.D. Anderson Cancer Center.

U.S. House of Representatives

• On December 5, the House Committee on Energy & Commerce hosted a markup entitled, A Full Committee Markup of 44 Pieces of Legislation. 41 bills were adopted and ordered reported favorably to the Full House of Representatives. Two bills, H.R. 6369 To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models, and H.R.6366 To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program, were postponed. While H.R. 6369 was not considered on its own, an amended version of version of the bill was considered as part of H.R. 6545, Physician Fee Schedule Update and Improvements Act. One bill, H.R.6568 To prohibit speculative ticketing as an unfair or deceptive act or practice, and for other purposes was withdrawn.

III. Reports, Studies, & Analyses

• On December 4, the Bipartisan Policy Center (BPC) released a report entitled, Strengthening the Integrated Care Workforce. The report advocates for an integrated approach to primary care, mental health, and substance use disorder (SUD) treatment to close the behavioral health treatment gap. The report highlights a number of recommendations to achieve integrated care teams that center on staff recruitment and training, payment and administrative strategies, and network requirements and flexibilities. The report argues that not only will an integrated approach to behavioral and primary health care increase access to care but will also improve health outcomes and increase the cost-effectiveness of care.
• On December 4, 2023, Health Affairs released a report entitled, FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels. The report finds that FDA inspections of U.S. and foreign drug manufacturing facilities dropped by 35% and 79%, respectively, between 2019 and 2022. In the early days of the COVID-19 pandemic, FDA paused many inspections but claimed they would resume work in July 2020; however, this report illustrates how far behind FDA is on inspections compared to pre-pandemic rates. The report highlights how fragile the drug supply chain is, especially at a time when many critical drugs are in low supply.

IV. Other Health Policy News

• On December 5, 2023, Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, issued a press release seeking stakeholder input on safely and responsibly expanding access to gene therapy treatments. This input will be used to draft legislation that outlines insurance coverage requirements and payment frameworks for these costly but vital treatments. The letter acknowledges the growing utilization of costly gene therapy treatments, citing estimates that by 2034, over one million individuals will receive a gene therapy treatment whose costs could reach up to $12.2 billion. The letter lays out a series of 59 questions to inform future legislation, including information on what treatments should be covered, how are gene therapies covered now, and what the future of gene therapies looks like.
• On December 6, 2023, HHS unveiled a concept paper centered on fortifying cybersecurity in the healthcare sector, aligning with President Biden’s National Cybersecurity Strategy. This strategy aims to enhance resilience against cyber threats for hospitals, patients, and communities. HHS is focusing on four key areas: setting voluntary healthcare-specific cybersecurity goals, collaborating with Congress to bolster support and incentives for hospitals, reinforcing accountability and coordination within the healthcare sector, and expanding HHS’s role as a central hub for healthcare cybersecurity. The initiative responds to a significant surge in cyber incidents in healthcare, posing risks to patient safety and prompting the administration to address vulnerabilities through standards, resources, and coordination efforts outlined in the concept paper. A press release is available here.
• On December 7, 2023, HHS, and the Department of Veterans Affairs (VA) have renewed a Reimbursement Agreement through the Indian Health Service (IHS). The agreement aims to improve the healthcare access and services for American Indian and Alaska Native veterans. It involves the VA reimbursing IHS for health care services provided to eligible Native veterans, covering areas such as direct care, outpatient pharmacy services, purchased/referred care, and contracted travel. This updated agreement expands upon a prior 2012 agreement, ensuring better quality care and financial compensation for services provided to veterans. The collaboration between these agencies emphasizes cultural competence and aims to serve veterans effectively. A press release is available here.
• On December 7, 2023, the Biden Administration announced new actions to lower prescription drug and health care costs by promoting competition in the healthcare and pharmaceutical industry through multiple approaches:

1. Supporting Independent Practices and Promoting Value Based Care Models: Initiatives like the Making Care Primary (MCP) Model aim to assist physician practices in adopting payment models that support prospective, population-based payments that support the delivery of advanced primary care. Additional efforts are underway to develop payment models that support doctors to transition to value-based care in their practices.
2. Promoting Equitable Access to Affordable Drugs: The Administration aims to ensure that taxpayer-funded drugs are reasonably priced and accessible by exploring avenues for pricing control and affordability in the context of drugs developed by taxpayer funds. The Department of Commerce (DOC) and the Department of Health and Human Services (HHS) released a proposed framework for agencies on the exercise of march-in rights that specifies for the first time that price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public. DOC and HHS invite public input on how this framework can promote access to taxpayer-funded inventions, including treatments for patients, while promoting innovation.
3. Addressing Anticompetitive Practices: Measures are being taken to address mergers and acquisitions that reduce competition in healthcare markets leading to increased costs and lower quality of care.
4. Increasing Healthcare Market Transparency: The Administration is enhancing ownership transparency in various healthcare sectors such as hospitals, nursing facilities, and Medicare Advantage (MA) plans to allow for better evaluation of market consolidation and its impact. With regard to MA plans, the Centers for Medicare & Medicaid Services (CMS) must have comprehensive and high-quality MA programmatic data, including understanding the effects of market shifts on consumers and care outcomes. CMS announced a new phase of this work, which will start with soliciting information from the public early next year to strengthen CMS’s data capabilities and MA transparency efforts.
5. Promoting Hospital Transparency: The Administration aims to bolster regulations that enforce hospital price transparency and allow patients to access information about hospital charges. Last month, CMS strengthened these regulations to require hospitals to make charges available in a more standardized manner to streamline enforcement capabilities. This will help the public learn how much an insurance company pays for a particular hospital service, for third parties to develop consumer-friendly materials, for hospitals to comply with federal requirements, and for CMS to enforce the regulations.

• The fact sheet is available here.

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